Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR— 510(k) K251807
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K251807 for Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR, Substantially Equivalent on 2026-03-06. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Summary
Olympus Medical Systems' Single Use Electrosurgical Hemostatic Forceps are filed under KGE, electric biopsy forceps. The name lists three models: FD-410LR, FD-411UR and FD-412LR.
Class II, 21 CFR 876.4300. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
Olympus Medical Systems filed from Hachioji-Shi, Japan. The decision came 267 calendar days after receipt (June 12, 2025 to March 6, 2026).
Clearance details
- Applicant
- Olympus Medical Systems Corp.
- Product code
- Product code KGE
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hachioji-Shi, JP
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Data sourced from openFDA. This site is unofficial and independent of the FDA.